MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-03 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-04-04-L manufactured by Aga Medical Corporation.
[183946763]
As reported in a research article, left pulmonary artery obstruction were noted during follow up after implantation with a 4-4 amplatzer piccolo. The results of the investigation are inconclusive since the device remains implanted was not returned for analysis. A review of the measurements as reported from the field was performed. Per the sizing table in the instructions for use, arten600042307 version a, the correct size piccolo occluder for the measurements provided was 04-02, smaller than the implanted device. The cause of the reported event could not be conclusively determined, however the implantation of a larger than recommended device could have contributed.
Patient Sequence No: 1, Text Type: N, H10
[183946764]
Reference manufacturing report number: 2135147-2020-00090, 2135147-2020-00091, 2135147-2020-00093, 2135147-2020-00094. It was reported through a research article identifying amplatzer piccolo that may be related to a severe left pulmonary artery obstruction. Details are listed in the article, titled "device deformation and left pulmonary artery obstruction after transcatheter patent ductus arteriosus closure in preterm infants. " it was reported in the article that in (b)(6) 2016, 14 patients underwent transcatheter patent ductus arteriosus (pda) closure. An (b)(6) days old patient that weight (b)(6) grams with pda diameter of 1. 89mm and pda length of 7. 89mm was implanted with a 4-4 amplatzer piccolo. During follow up, severe left pulmonary artery obstruction was observed. The patient was asymptomatic and no intervention was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00092 |
| MDR Report Key | 9783115 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | AGA MEDICAL CORPORATION |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER PICCOLO OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-03 |
| Model Number | 9-PDAP-04-04-L |
| Catalog Number | 9-PDAP-04-04-L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGA MEDICAL CORPORATION |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |